Contemporary real-world evidence in unresectable HCC (uHCC) patients treated with regorafenib in Taiwan: Interim results from the observational REFINE study.

Authors

null

Shi-Ming Lin

Chang Gung Memorial Hospital, Taipei, Taiwan

Shi-Ming Lin , Chih-Hung Hsu , Long-Bin Jeng , Yih-Jyh Lin , Ming-Yang Lee , Teng-Yu Lee , Yi-Hsiang Huang

Organizations

Chang Gung Memorial Hospital, Taipei, Taiwan, National Taiwan University Cancer Center, Taipei City, Taiwan, China Medical University Hospital, Taichung, Taiwan, National Cheng Kung University Hospital, Tainan, Taiwan, Chiayi Christian Hospital, Chiayi, Taiwan, Taichung Veterans General Hospital, Taichung, Taiwan, Division of Gastroenterology and Hepatology, Taipei Veterans General Hospital, Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan

Research Funding

Pharmaceutical/Biotech Company

Background: The phase 3 RESORCE trial showed that regorafenib improved overall survival compared to placebo in uHCC patients (pts) who progressed on sorafenib. The characteristics of real-world pts are more diverse than those included in clinical trials. The global observational REFINE study was designed to evaluate the safety and effectiveness of regorafenib in pts with uHCC in a real-world setting. Methods: REFINE is an ongoing observational study of pts with uHCC who were treated with regorafenib in routine practice. The primary end point includes to assess treatment-emergent adverse events (TEAEs; NCI-CTCAE v4.03). Secondary endpoints include overall survival, progression-free survival, and tumor response. Tumor response and progression are assessed per investigator according to local standard. A planned interim analysis of 1008 pts in the global cohort has been reported (Lim, ILCA 2021). We describe interim results in pts from Taiwan. Results: A total of 137 pts were enrolled and 136 were valid for safety analysis (80% male). At study entry, median age was 65.5 years (Q1-Q3, 60-72); 51.5% pts had an ECOG PS 0 and 24.3% and 12.5% had an ECOG PS of 1 and, respectively (missing 11.8%); proportion of pts classified as Child–Pugh A/B/C were 46.3%/10.3%/0.7% (missing/not evaluable: 40.4%/2.2%). The initial daily regorafenib dose was 160 mg in 8% of pts and 120 mg/80 mg in 9%/78%; 5.1% started at 40 mg. 83.1% pts received regorafenib as a second line agent and 15.4% pts as third line or beyond. 132 pts had prior sorafenib treatment with last daily dose being 400mg in 53.8% of patients; 9 patients (6.6%) had received an immune checkpoint inhibitor. The most frequent TEAEs are shown (Table). Effectiveness results will be presented. Conclusions: The characteristics of real-world pts from Taiwan not only differ from those in the RESORCE trial but also from the global REFINE cohort, reflecting variation across countries. A higher proportion of patients from Taiwan initiated regorafenib at a lower dose. Clinical trial information: NCT03289273.

Most frequent treatment emergent adverse event.

n(%)
Total, n= 136

Any grade
≥grade 3
Abdominal pain
17 (12.5)
3 (2.2)
Hypertension
25 (18.4)
4 (2.9)
Decreased appetite
31 (22.8)
4 (2.9)
Fatigue
41 (30.1)
3 (2.2)
Diarrhea
58 (42.6)
9 (6.6)
HFSR
59 (43.4)
7 (5.1)

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Abstract Details

Meeting

2022 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Pancreatic Cancer,Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Small Bowel Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Clinical Trial Registration Number

NCT03289273

DOI

10.1200/JCO.2022.40.4_suppl.402

Abstract #

402

Poster Bd #

M8

Abstract Disclosures